Product Alert

FDA Approves Icatibant for Rare Swelling Condition

WASHINGTON -- The FDA has approved the injectable drug icatibant (Firazyr) to treat acute hereditary angioedema (HAE) attacks, making it the first such medication available in the U.S. that patients with the rare genetic condition can administer themselves.

HAE affects up to 8,000 people in the U.S., according to icatibant maker Shire.

Patients with HAE suffer periodic, painful attacks of severe swelling in various parts of the body including hands, feet, face, abdomen, and sometimes the throat, which can cause airway restriction.

It is caused by a deficiency in the C1 esterase enzyme, which regulates inflammatory and coagulation responses. Defective C1-inhibitor can cause a biochemical imbalance that can produce unwanted peptides, which, in turn, induce the capillaries to release fluids into surrounding tissues, causing the swelling.

Icatibant can be self-administered, which is especially important since attacks can be unpredictable and become life-threatening rapidly, according to Shire.

"Until now, HAE patients faced challenges gaining rapid access to acute treatment such as the need to travel to the physician's office or hospital," Timothy Craig, MD, professor of Medicine at Penn State Hershey Medical Center said a press release from Shire.

"FIRAZYR is a treatment with demonstrated efficacy that can be carried and stored at room temperature and self-injected by the patient. FIRAZYR addresses this important unmet need by providing HAE patients with fast access to acute treatment."

In July, an FDA advisory committee voted 12-1 to recommend approval for the drug based on the company's phase III trial of 98 patients that found icatibant cut median time to clinically significant relief from acute swelling and pain to two hours compared with 19.8 hours on placebo (P<0.001).

Adverse events were not a concern in any of the company's trials.

Icatibant is already approved in 38 countries.

There are two other drugs -- Kalbitor and Berinert -- that are FDA-approved to treat HAE attacks, but they must be administered in a medical setting. Another drug, Cinryze, can be self-administered, but it is prophylactic and is not approved to manage acute attacks.

Emily P. Walker, MedPage Today Washington Correspondent, covers Congress, FDA, other health agencies in Washington. She also covers an array of healthcare events in the nation’s capital, focusing on intersection of policy and medicine. After earning a BA in journalism and political science at Western Michigan University, she worked at the Kalamazoo Gazette, Congressional Quarterly, and wrote for several medical newsletters.

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